Status:
NOT_YET_RECRUITING
Early Versus Late Upper Extremity Mobilization After Meshed / Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
STSGs are used to close wounds and minimize infections. After receiving a meshed or sheet split-thickness skin graft (STSG) to the upper extremity or hand for a thermal burn injury, burn surgeons use ...
Eligibility Criteria
Inclusion
- Age: 18 years and older at the time of surgery.
- Injury: Acute (within 72h of injury) thermal flame or scald burn.
- Surgery: Skin split-thickness meshed autograft (STSG) and/or sheet split thickness autograft (STSG) applied directly on the wound bed.
- Location:
- Upper extremity burn - distal to the axilla and proximal to the wrist. The axilla is a difficult area to graft due to its three-dimensional configuration, hence the healing of this area is not comparable to others.
- The hand that will undergo sheet STSG
Exclusion
- Injury: Electrical and chemical burn. The pathophysiology of electrical or chemical burns is not comparable to flame or scald burns, hence their exclusion.
- Location: Autograft exclusively to the wrist, axilla, or non-upper extremity. The wrist is a sensitive areas with many joints in close proximity. The loss of graft in this area can be devastating to the patient and will therefore be evaluated only once we have evidence to support the safety of mobilization in upper extremity grafts.
- Patients on vasopressors the day of the operation. Vasopressors cause peripheral vasoconstriction, leading to decreased wound healing capacity. Patients on vasopressors are also usually systemically unwell and should therefore not be included in an elective clinical trial on extremity mobilization.
- Pre-existing comorbidities causing upper extremity mobility restrictions.
- Patient unable to comply with mobilization protocol.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06143683
Start Date
January 1 2024
End Date
July 1 2028
Last Update
December 8 2023
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